Health Product InfoWatch: September 2023

Contents

• Health products mentioned in this issue
• Monthly recap of health product safety information
• Online pharmacies: Marketing of drugs and medical devices
• Scope
• Reporting Adverse Reactions
• Helpful links
• Suggestions?

Health products mentioned in this issue

Pharmaceuticals and biologics

• Amitriptyline
• Apo-Acyclovir
• Domperidone
• Keytruda (pembrolizumab)
• Sabril (vigabatrin)
• Tecentriq (atezolizumab)

Natural and non-prescription health products

• Cromolyn Eye Drops

Other

• Unauthorized Health Products

Monthly recap of health product safety information

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in August 2023 by Health Canada.

Amitriptyline

Certain lots of amitriptyline tablets were recalled as the affected lots exceeded the interim acceptable intake limit for N-nitroso-nortriptyline (NNORT) or exceeded the acceptable cumulative intake limit for N-nitrosodimethylamine (NDMA) and NNORT.

• Type 1 drug recall: Amitriptyline
• Type 1 drug recall: Apo-Amitriptyline
• Type 1 drug recall: Elavil
• Type 1 drug recall: Pms-Amitriptyline

Apo-Acyclovir

Certain lots of Apo-Acyclovir tablets were recalled as the affected lots exceeded the concentration intake limit for NDMA.

• Type 1 drug recall: Apo-Acyclovir

Cromolyn Eye Drops

The Pendopharm Division of Pharmascience Inc. recalled all lots of the 10 mL format of Cromolyn Eye Drops due to the risk of microbial growth.

Advisory: Cromolyn Eye Drops

Domperidone

This safety review evaluated the risk of psychiatric withdrawal events following sudden discontinuation or tapering of domperidone used to stimulate lactation. Health Canada's review found a link, which was mostly observed in patients taking daily doses greater than the maximum recommended dose of 30 mg per day. Health Canada will work with the manufacturers to update the Canadian product monographs for domperidone-containing products to note that cases of psychiatric withdrawal events have been reported. Health Canada has also communicated this information to healthcare professionals.

• Summary Safety Review: Domperidone
• Health Product InfoWatch: Domperidone

Keytruda (pembrolizumab) and Tecentriq (atezolizumab)

This safety review evaluated the risk of aplastic anemia associated with Keytruda (pembrolizumab) or Tecentriq (atezolizumab). Health Canada's review found a link. The review also found that the risk applied to all members of the immune checkpoint inhibitor drug class. Health Canada is working with the manufacturers to update the Canadian product monographs for Keytruda and Tecentriq, as well as for the other products in the immune checkpoint inhibitor drug class that are not currently labelled for this risk.

• Summary Safety Review: Keytruda (pembrolizumab) and Tecentriq (atezolizumab)

Sabril (vigabatrin)

Two lots of Sabril (vigabatrin) 500 mg powder for oral solution, in sachet format, were found to contain trace amounts of another prescription drug, tiapride. Health Canada has determined that the health risk of the trace contamination to patients is low. It is important that patients do not stop taking their Sabril as prescribed without consulting their physician, as the benefits of this drug are expected to outweigh its potential risks despite trace amounts of tiapride, unless patients have a severe allergy to tiapride.

• Advisory: Sabril (vigabatrin)

Unauthorized Health Products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.

• Advisory: Unauthorized health products seized from stores in the Greater Toronto Area
• Advisory: Unauthorized health products seized from Yang Sheng Health Food and G&R Ginseng Trading stores in Richmond, B.C.
• Advisory: Unauthorized sexual enhancement products
• Advisory: Unauthorized skin lightening and skin treatment products

Online pharmacies: Marketing of drugs and medical devices

In Canada, pharmacies and/or pharmacy owners are regulated by the pharmacy regulatory authority in the jurisdiction (province or territory) where the business is established. A legitimate pharmacy and/or pharmacy owner, including online pharmacies and owners of online pharmacies, will thus be licensed by the pharmacy regulatory authority in that province or territory.^{Footnote 1}

Health Canada is the national regulatory authority for drug and medical device advertising and as such, is responsible for ensuring compliance with federal advertising legislation and regulations. Health Canada would like to remind healthcare professionals and online pharmacy owners that online pharmacies in Canada are subject to the Canadian federal legislation related to advertising of health products.

Health Canada's Stop Illegal Marketing of Drugs and Devices (SIM-DD) program is a platform that provides support to healthcare professionals in understanding, identifying, and reporting illegal marketing of drugs and medical devices. The SIM-DD program also helps healthcare professionals and online pharmacy owners avoid engaging in illegal advertising when promoting health products and/or services to consumers.

Healthcare professionals are encouraged to report any suspected illegal online pharmacy advertising to Health Canada.

Scope

This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

Reporting Adverse Reactions

Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada

For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.

Helpful links

• MedEffect^TM Canada
• Recalls and Safety Alerts Database
• New Safety and Effectiveness Reviews
• Canada Vigilance Adverse Reaction Online Database
• Drug Product Database
• Medical Devices Active Licence Listing
• Licensed Natural Health Products Database
• The Drug and Health Product Portal
• Drug Shortages Canada
• Medical device shortages: List of shortages and discontinuations
• Stop Illegal Marketing of Drugs and Devices
• List of drugs for exceptional importation and sale
• Coronavirus disease (COVID-19)
• Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications
• COVID-19 vaccines and treatments portal
• Reported side effects following COVID-19 vaccination in Canada

Suggestions?

Your comments are important to us. Let us know what you think by reaching us at:
infowatch-infovigilance@hc-sc.gc.ca

Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Teletypewriter: 1-800-465-7735 (Service Canada)